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Evaluation of a Closed-Loop Control System for Administering Patient-Specific Anesthesia

This study has been completed.
Information provided by (Responsible Party):
Stanford University Identifier:
First received: May 22, 2008
Last updated: November 22, 2011
Last verified: November 2011
Numerous efforts have focused on the development of closed-loop systems to control anesthesia using the electrical activity of the brain (EEG) and EEG-based parameters as surrogate measures of anesthetic depth. New systems have been recently developed to considerably improve anesthetic control using model-based, patient-adaptive methods. The purpose of this study is to evaluate the clinical efficacy of a new intelligent software, ReinLoop, in delivering closed-loop, patient-specific hypnosis.

Condition Intervention Phase
Anesthesia, General Device: ReinLoop control software for patient-specific induction and maintenance of anesthesia Drug: Propofol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Official Title: Evaluation of a Closed-Loop Control System for Patient-Specific Induction and Maintenance of Propofol Hypnosis

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To evaluate the clinical efficacy of the ReinLoop agent in delivering closed-loop, patient-specific hypnosis.

Estimated Enrollment: 35
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 18-45 years of age
  2. Body mass index (BMI) lower or equal to 25 m2/kg
  3. Subjects must be able to comprehend spoken and written English

Exclusion Criteria:

  1. Any type of psychiatric, neurological, or neuromuscular disorder
  2. Thyroid disease
  3. History of smoking
  4. Alcohol consumption which exceeds 2 drinks per day and /or drug abuse. Volunteers will be asked the question: How many drinks are you drinking on your typical day?
  5. Allergy to study medication (propofol), soy, or egg proteins.
  6. History of drug abuse
  7. Chronic or acute use of opioids, or other medications affecting the CNS
  8. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00683956

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Anthony Doufas Stanford University
  More Information

Responsible Party: Stanford University Identifier: NCT00683956     History of Changes
Other Study ID Numbers: SU-05062008-1141
Study First Received: May 22, 2008
Last Updated: November 22, 2011

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General processed this record on September 20, 2017